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Gene patent lawsuit aims to clear up confusion in Canada

Can human genes be patented? On Monday, an Ottawa hospital filed a legal challenge that will bring that bioethical conundrum to Canadian courts.

The U.S. Supreme Court ruled in 2013 that it isn’t possible to patent naturally occurring genes because they are products of nature, throwing out patents on the BRCA1 and BRCA2 genes. Harmful mutations in those genes are associated with an increased risk of breast and ovarian cancer, and testing for the mutations became cheaper and more widely available after the U.S. ruling.

European courts have also considered the question. But Canadian courts are “behind the times,” said Richard Gold, a law professor at McGill who is involved with the case.

Monday’s claim, filed in federal court by the Children’s Hospital of Eastern Ontario (CHEO), deals with five patents held in Canada by the University of Utah, Genzyme Genetics and Yale University on gene sequences and tests for an inherited cardiac condition called Long QT syndrome.

The disorder causes chaotic heart beats and can lead to fainting, seizures and sudden death — it is often responsible for stories of otherwise-healthy teenagers dying suddenly in the middle of sports matches. It is treatable, but the rights to the test involved in diagnosis are held exclusively by U.S. labs.

CHEO believes it could perform the necessary screening for approximately half of the current $4,500 (U.S.) cost associated with sending patients’ blood samples stateside.

“Long QT is just one of thousands and thousands of genetic conditions. So (the case) is specifically about Long QT, but really it’s a much broader issue about the future of medicine and delivering on the potential of recent technology,” said Alex Munter, president and CEO of the hospital.

Jehannine Austin, a genetic counsellor and Canada Research Chair in translational psychiatric genetics at the University of British Columbia, says the part of the legal challenge related to gene patents is a “distraction,” however.

“It’s kind of irrelevant whether or not they hold the patent for the gene sequence itself — it’s the test that’s important,” said Austin.

CHEO won a contract from the Ontario Ministry of Health to provide screening for an array of inherited cardiac disorders, Gail Graham, chief of the hospital’s genetics program, told the Star. But the province received a warning letter from the patent holder for the Long QT tests, Graham said, so that test was excluded.

The hospital is also validating a commercially available test that can diagnose 5,000 genetic conditions simultaneously, but believes gene patenting hinders the use of it.

“I could conceivably be sitting across the table from a patient who has Long QT syndrome and not be able to tell them that they have that condition, even though it’s detectable on the test, because of these patents,” said Graham.

Monday’s lawsuit also claims that invalidating the patents would allow CHEO to build the first repository in Canada of genetic information on Long QT syndrome, which would in turn improve diagnosis and treatment.

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It is not known how many gene patents exist in Canada; researchers have estimated they number in the thousands.

The defendants have 40 days to respond to the suit, but the case could take a year or longer to reach trial. Neither the University of Utah nor the other two named defendants provided a statement in response to the legal challenge before press time.

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